Menopur 75unit powder and solvent for solution for injection vials

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Menotrophin

זמין מ:

Ferring Pharmaceuticals Ltd

קוד ATC:

G03GA02

INN (שם בינלאומי):

Menotrophin

כמות:

75unit

טופס פרצבטיות:

Powder and solvent for solution for injection

מסלול נתינה (של תרופות):

Intramuscular; Subcutaneous

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 06050100; GTIN: 5015919649238 05015919648613

עלון מידע

Patient Information
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or
pharmacist.
• This medicine has been prescribed for you. Do not pass it
on to others. It may harm them, even if their symptoms are
the same as yours.
• If any of the side effects become serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor, nurse or pharmacist.
IN THIS LEAFLET:
1. What Menopur is and what it is used for
2. Before you use Menopur
3. How to use Menopur
4. Possible side effects
5. How to store Menopur
6. Further information
1. WHAT MENOPUR IS AND WHAT IT IS USED FOR
WHAT MENOPUR IS
Menopur contains a medicine called menotrophin. This is a
mixture of hormones obtained from the urine of women who
have passed the menopause.
• The dose of these hormones is given in International Units
(IU).
• Each bottle (vial) contains the equivalent of 75 IU of FSH
(follicle stimulating hormone) and 75 IU of LH
(luteinising hormone).
Menopur helps reproductive organs to work normally in
both women and men. A fertility specialist should supervise
your treatment.
WHAT MENOPUR IS USED FOR
IN WOMEN, Menopur is used for:
• Infertility caused by eggs not being produced properly in
the ovaries (anovulatory infertility). It works by helping
follicles (which contain eggs) to mature in the ovaries.
• IVF (in vitro fertilisation) and other types of ‘assisted
conception’. It works by helping multiple follicles and
eggs to develop. The eggs are then harvested and
fertilised outside the body.
IN MEN, Menopur is used for:
• Low sperm count (oligospermia).
ALSO, IF YOU ARE A WOMAN DO NOT USE MENOPUR IF:
• You have tumours of your womb (uterus), ovaries or
breasts.
• You have cysts on your ovaries or enlarged ovaries that
are not due to polycystic ovary syndrome (a condition
that prevents eggs from being released from the ovaries).
• You have bleeding from your v

מאפייני מוצר

OBJECT 1
MENOPUR 75IU
Summary of Product Characteristics Updated 03-Jun-2016 | Ferring
Pharmaceuticals Ltd
1. Name of the medicinal product
MENOPUR
®
2. Qualitative and quantitative composition
_Active ingredient_
Each vial with dry substance contains highly purified menotrophin
(human menopausal gonadotrophin,
HMG) corresponding to 75 IU human follicle stimulating hormone (FSH)
and 75 IU human luteinising
hormone (LH).
3. Pharmaceutical form
Powder for injection; and solvent for parenteral use.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of female and male infertility in the following groups of
patients:
- Anovulatory women: MENOPUR can be used to stimulate follicle
development in amenorrhoeic
patients. Clomiphene (or a similar ovulation inducing agent which
influences steroid feed-back
mechanisms) is the preferred treatment for women with a variety of
menstrual cycle disturbances,
including luteal phase insufficiency with anovulatory cycles and with
normal prolactin, and also
amenorrhoeic patients with evidence of endogenous oestrogen production
but normal prolactin and
normal gonadotrophin levels. Non-responders may then be selected for
menotrophin therapy.
- Women undergoing superovulation within a medically assisted
fertilisation programme: MENOPUR
can be used to induce multiple follicular development in patients
undergoing an assisted conception
technique such as in-vitro fertilisation (IVF).
- Hypogonadotrophic hypogonadism in men: MENOPUR may be given in
combination with human
chorionic gonadotrophin (e.g. Choragon) for the stimulation of
spermatogenesis. Patients with primary
testicular failure are usually unresponsive.
4.2 Posology and method of administration
Anovulatory infertility:
Menotrophin is administered to induce follicular maturation and is
followed by treatment with chorionic
gonadotrophin to stimulate ovulation and corpus luteum formation.
The dosage and schedule of treatment must be determined according to
the needs of each patient.
Response is monitored by studying the p